EUCTR2007-003312-65-EE进行中（未招募）不适用
Efficacy and safety of 2 doses of S 90098 (1 and 2mg/day), sublingual formulation for 8 weeks in out-patients with Major Depressive Disorder. An 8-week randomised, double-blind, fixed dose, international, multicentre, placebo-controlled study with parallel groups, followed by an extension double-blind treatment period for 16 weeks. - FIGARO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Outpatients between 18 (or minimum legal age) and 70 years of age (included), male or female, fulfilling DSM-IV criteria for Major Depressive Disorder
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •All types of depression other than Major Depressive Disorder
- •Severe or uncontrolled organic disease, likely to interfere with the conduct of the study
- •Women of childbearing potential without effective contraception (oral contraceptive pill, intra-uterine contraceptive device, contraceptive implant or condom) as well as pregnant or breastfeeding women
研究者
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Efficacy and safety of 2 doses of S 90098 (1 and 2mg/day), sublingual formulation for 8 weeks in out-patients with Major Depressive Disorder. An 8-week randomised, double-blind, fixed dose, international, multicentre, placebo-controlled study with parallel groups, followed by an extension double-blind treatment period for 16 weeks.MedDRA version: 9.1Level: LLTClassification code 10057840Term: Major depressionMajor Depressive DisorderEUCTR2007-003312-65-FRInstitut de Recherches Internationales Servier240
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Efficacy and safety of 2 doses of S 90098 (1 and 2mg/day), sublingual formulation for 8 weeks in out-patients with Major Depressive Disorder. An 8-week randomised, double-blind, fixed dose, international, multicentre, placebo-controlled study with parallel groups, followed by an extension double-blind treatment period for 16 weeks.Major Depressive DisorderEUCTR2007-003312-65-LTInstitut de Recherches Internationales Servier240
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Efficacy and safety of 2 doses of S 90098 (1 and 2mg/day), sublingual formulation for 8 weeks in out-patients with Major Depressive Disorder. An 8-week randomised, double-blind, fixed dose, international, multicentre, placebo-controlled study with parallel groups, followed by an extension double-blind treatment period for 16 weeks. - FIGAROMedDRA version: 9.1Level: LLTClassification code 10057840Term: Major depressionMajor Depressive DisorderEUCTR2007-003312-65-CZInstitut de Recherches Internationales Servier240
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Efficacy and safety of 2 doses of S 90098 (1 and 2mg/day), sublingual formulation for 8 weeks in out-patients with Major Depressive Disorder. An 8-week randomised, double-blind, fixed dose, international, multicentre, placebo-controlled study with parallel groups, followed by an extension double-blind treatment period for 16 weeks. - FIGAROMedDRA version: 9.1Level: LLTClassification code 10057840Term: Major depressionMajor Depressive DisorderEUCTR2007-003312-65-FIInstitut de Recherches Internationales Servier240
已完成
2 期
Efficacy and safety of two doses of S 90098 (1 and 2 mg/day), sublingual formulation for 8 weeks in out-patients with major depressive disorder: An 8-week randomised, double-blind, fixed dose, international, multicentre, placebo-controlled study with parallel groups, followed by an extension double-blind treatment period for 16 weeksMajor depressive disorderMental and Behavioural DisordersRecurrent depressive disorderISRCTN38378163Institut de Recherches Internationales Servier (France)264